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Cases - The Changing Values Landscape of the U.S. and How It Impacts Midlife Job Searchers
Imagine a huge river that has been flowing for centuries: See the thick underbrush that has grown up on either edge of the river’s expansi
According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product
ve banks and the moss-lined stones that litter its shallow edges. Feel the power of water so deep and so strong because it has been pulsing th
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
rough this landscape since the Renaissance, yet now this mighty river approaches a “Great Divide” such as has never been seen before in human h
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
story.
There really is such a river and such a Great Divide and you will witness their inevitable collision in your lifetime. Why doe
There really is such a river and such a Great Divide and you will witness their inevitable collision in your lifetime. Why doe
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
s this matter? Because you will observe the Great Divide from within it and will likely experience personal and professional chaos as a result
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
, especially if you now or soon face the chapter of life we call Midlife. To smooth your own midlife transition, you need to preview the chaos
ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc
up ahead so that you can prepare to ride out the coming storm of change which you cannot escape except at the price of your life. But fear not
easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi
, help is at hand! Institute of Noetic Sciences (IONS) research Dr. Paul H. Ray will guide us through the turbulence he foresees (through the
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
archives on www.noetic.org check out a summary of Dr. Ray’s research entitled “The Rise of I
and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ
tegral Culture”).
Through his research, Dr. Ray has discovered that this tremendous values shift now underway in the U.S will remake c
Through his research, Dr. Ray has discovered that this tremendous values shift now underway in the U.S will remake c
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
ivilization as we know it. In the words of Dr. Ray: “At the threshold of a “Great Divide” in history such as this, the worst upset may be to
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
know you are at a watershed where the given world diverges sharply from everything you have known, and have been, into the unknown.” He goes o
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
to say that, “In the next two decades our world will either be dramatically better or dramatically worse. The one thing that cannot happen is
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
just ‘more of the same’. … We are at a tipping point in civilization. This means we have to be ready to choose a good path. The quality of
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
our ‘image of the future’, and the quality of our creative efforts based on it, will determine which way our future develops over the next gene
t?
As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel
As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel
ation or two.”
What does all of this have to do with you and your midlife transition? You stand at the threshold of your own personal Great
What does all of this have to do with you and your midlife transition? You stand at the threshold of your own personal Great
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
Divide which will propel you into the unknown you may have been postponing. Your future life will either be better or worse. Which do you ch
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
oose? Are you ready to choose a good path for the rest of your life? Do you know what that looks like for you? Do you understand how your cr
.
As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de
As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de
ativity fits into this picture of your future life? Do you know what you value and why? Do you consciously make decisions that are based on y
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
our values? If these questions speak to your heart, then stay tuned for Part Two of this article as “News from the Great Divide” continues!
tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products
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